PHAR 628 Research Methods & Biostatistics Lecture 1 PDF

PHAR 628 Research Methods & Biostatistics Lixian Zhong, Ph.D. Jan 15th, 2025 PHAR628 LECTURE 1 1 Drug Research and Development Process PHAR628 LECTURE 1 2 ...

PHAR 628 Research Methods & Biostatistics Lixian Zhong, Ph.D. Jan 15th, 2025 PHAR628 LECTURE 1 1 Drug Research and Development Process PHAR628 LECTURE 1 2  PHAR 628 Research Methods and Biostatistics PHAR628 LECTURE 1 3  Education Agenda The Accreditation Council for Pharmacy Education (ACPE) required pharmacist training to incorporate: (i) principles of research design and methodology; (ii) regulatory and ethical principles of research; (iii) data management and statistical analyses; (iv) principles of drug literature evaluation; (v) practice implications of research. Sound understanding of the scientific basis of patient care is essential for pharmacists to succeed in a highly competitive health care arena. PHAR628 LECTURE 1 4  Why PHAR 628 Research Methods and Biostatistics? By the end of the course, you will be able to: ❑Define clinical research and identify how it is conducted; ❑Understand different research designs for clinical research, in particular for clinical trials; ❑Identify how to “connect” research issues to clinical practice; ❑Interpret common biostatistics in the clinical and scientific literature, with reference to a biostatistics text as needed; ❑Interpret the meaning of graphs and tables in scientific articles; ❑Formulate research questions and hypotheses and incorporate them into research proposals; ❑Review medical/pharmacy-related scientific articles, identify the questions and hypotheses addressed, and summarize the conclusions reached; ❑List the main research methods used in research articles, and the results supporting the conclusions; ❑Evaluate the strength of the evidence supporting the conclusions and the support of evidence-based clinical practice through clinical and scientific research. PHAR628 LECTURE 1 5  Course Instructor Lixian Zhong, PhD Associate Professor (with tenure) Course coordinator and lecturer Office: CS Reynolds Building Suite 304B Telephone: (979) 436-0193 E-mail: [email protected] Teaching: PHAR628, PHAR757, PHSC621 PHAR628 LECTURE 1 6  PHAR 628 Course Overview Course meeting time: Wednesday & Friday 9:00 AM - 9:50 AM Office hours: Friday 12-1 PM or by appointment Zoom link: https://tamu.zoom.us/j/9794360193 PHAR628 LECTURE 1 8 PHAR628 Course Overview 1st Exam 2nd Exam Final (2/21, Friday) (4/4, Friday) (During the final week) Research Biostatistics Biostatistics Methods PHAR628 LECTURE 1 9  Course materials (on Canvas) - Course syllabus and calendar - Announcements - Lecture notes - Self-paced quizzes - other materials PHAR628 LECTURE 1 10  Textbooks - A textbook is not required for this course. - Recommended: Principles of Research Design and Drug Literature Evaluation Rajender R. Aparasu and John P. Bentley. 2015 Jones & Bartlett learning PHAR628 LECTURE 1 11  Textbooks - A textbook is not required for this course. - Recommended: Foundations of Clinical Research- Application to Practice Portney LG & Watkins MP. 2nd Edition (2000) or 3rd Edition (2009) Prentice Hall Health: New Jersey PHAR628 LECTURE 1 12  Textbooks - A textbook is not required for this course. - Recommended: High-Yield Biostatistics Glaser AN 3rd Edition, 2005 Lippincott Williams & Wilkins: Baltimore, Maryland PHAR628 LECTURE 1 13  Class Attendance and Participation Attendance: - You are strongly recommended to attend the live lecture sessions - Lectures will be recorded Participation: - PollEverywhere questions - In-class exercises - Please feel free to ask questions in class - I may call on you to answer questions 2 points in the final grade will be based on your attendance and in-class participation. PHAR628 LECTURE 1 14  PHAR 628 Exams and Grading Key Assessments: Exam 1 28% Exam 2 28% Final 30% Self-paced Quizzes 12% Class participation 2% TOTAL 100% PHAR628 LECTURE 1 15  Exams and Make-up Exams - Exams will be held on Examsoft (Examplify) with backward navigation options. - With an excused absence (as deemed by the Office of Student Affairs), the student may earn up to 100% of the total number of points on the make-up exam. - If the absence is unexcused, the student will the student may earn up to 80% of the total number of points on the make-up exam. - The make up exam may take a different format from the original exam. PHAR628 LECTURE 1 16 PHAR 628 Research Methods & Biostatistics Lecture 1: Introduction to Research Lixian Zhong, Ph.D. Jan 15th, 2025 PHAR628 LECTURE 1 17  Lecture Objectives ❖To define concepts of different types of research - basic - applied - clinical - translational research PHAR628 LECTURE 1 18 PHAR628 LECTURE 1 19  Why Research? Now let’s think about some milestones in medical research: -Tobacco use & lung cancer -Decline in death from heart diseases -Early detection and treatment of cancer -Development of vaccines for infectious diseases PHAR628 LECTURE 1 23  Definition of Research Research “Systematic study directed towards fuller scientific knowledge or understanding of the subject studied” Source: National Science Foundation (NSF) Types of research ◦ Basic research ◦ Applied research PHAR628 LECTURE 1 24  Basic Research Defined as “systematic study directed toward fuller knowledge or understanding of the fundamental aspects of phenomena and of observable facts without specific applications towards processes or products in mind.” Usually conducted in laboratories to provide knowledge of natural phenomenon. PHAR628 LECTURE 1 25  Applied Research Defined as “systematic study to gain knowledge or understanding necessary to determine the means by which a recognized and specific need may be met.” Applied to develop a product or an application such as new medication, drug dosage regimen, service etc. PHAR628 LECTURE 1 26  Biomedical Research Research that deals with biological and medical sciences to understand and improve the health of patients and populations. Types of biomedical research ◦ Basic biomedical research ◦ Applied biomedical research PHAR628 LECTURE 1 27 Biomedical Research Continuum Basic Clinical Improved Biomedical Research Health Research Bench Bedside Clinical practice Adapted from Sung et al. (2003) JAMA, 289, 1278-89. PHAR628 LECTURE 1 28  Basic Biomedical Research Areas of inquiry-biology, physiology, biochemistry, cell biology, molecular biology, genetics… Basic research is important for applied research. PHAR628 LECTURE 1 29  Clinical Research Defined by National Institute of Health (NIH) as, “research that either directly involves a particular person or group of people or uses materials from humans, such as their behavior or samples of their tissue.” It includes a variety of research types, such as clinical trials, epidemiological research, health services research, outcomes research etc. clinical research ≠ clinical trial It helps in understanding and application of knowledge for products or processes in prevention, diagnosis, prognosis, treatment and cure of diseases in humans. clinical research ≠ clinical practice PHAR628 LECTURE 1 30  Evolving Research Paradigms Translational research is the new clinical research paradigm for transferring knowledge across the research and practice continuum. PHAR628 LECTURE 1 31 Biomedical Research Continuum Translation of new Translation from knowledge into clinical Basic science to practice and health human studies decision making Basic Clinical Improved Biomedical Research Health Research Adapted from Sung et al. (2003) JAMA, 289, 1278-89. PHAR628 LECTURE 1 32  Evolving Research Paradigms As per NIH, this research includes two areas of translation: ◦ T1: The process of applying discoveries generated during research in the laboratory and in preclinical studies, to the development of trials and studies in humans. ◦ T2: The second area of translation concerns research aimed at enhancing the adoption of best practices in community. PHAR628 LECTURE 1 33  Pharmacists and Research Pharmacists are a vital component of health care delivery and biomedical systems Pharmacists are consumers of research information Pharmacists can play an active role in creating and applying scientific evidence Pharmacists have made enormous contributions to both basic and applied research and have great potential to influence the future landscape of health care PHAR628 LECTURE 1 35